Chromatographic fingerprinting of ipratropium and fenoterol in their novel co-formulated inhaler treating major respiratory disorders; application to delivered dose uniformity testing along with greenness and whiteness assessment

Table 4 Results of delivered dose uniformity testing for determining Ipratropium and Fenoterol in Atrovent^® comp HFA using the proposed HPLC method

Atrovent^® comp HFA meter dose no.	Label claim (%)
	Group 1 (Inhaler 1; B.N. 104604)		Group 2 (Inhaler 2; B.N. 204632)
	IPR	FEN	IPR	FEN
1	100.42	98.85	100.49	103.48
2	97.37	103.89	99.73	97.78
3	97.52	104.56	103.41	103.48
4	100.76	104.51	102.73	103.74
5	100.60	100.37	100.68	104.18
6	103.20	103.79	98.21	103.94
7	101.38	101.13	100.69	103.61
8	102.62	99.07	101.55	103.90
9	103.07	102.65	102.35	99.76
10	102.24	103.49	105.45	103.33
Mean	100.92	102.23	101.53	102.72
SD	2.09	2.20	2.05	2.15
RSD%	2.07	2.15	2.02	2.09
AV^*	5.01	6.03	4.95	6.38

^* Acceptance value = |M − X̄ | + 2.4 × SD with maximum allowed level (L1) is 15

ISSN: 2661-801X